Dementia Clinical Trial
Official title:
Cohort Study on Biomarkers of Cognitive Disorders in China
Verified date | May 2024 |
Source | Xuanwu Hospital, Beijing |
Contact | Cuibai Wei |
Phone | 83198319 |
weicb[@]xwhosp.org | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Dementia is a syndrome characterized by progressive global cognitive impairment that impairs occupational, family, or social functioning. It detrimentally affects personal health and quality of life, imposing significant medical economy, social and psychological burden on the countries and the patients' family. The internationally renowned dementia cohort includes the DIAN that focused on genetics studies, the ADNI cohort featuring imaging and the FINGERS cohort focused on risk factor intervention, etc. Establishing standardized and shared longitudinal follow-up dementia cohorts and clinical database is an essential challenge for constructing dementia cohort in China. Moreover, there is a lack of large-scale prospective longitudinal follow-up cohorts within the Chinese population that cover subjective cognitive decline (SCD) to explore biomarkers with diagnostic and early warning value for different kinds of dementia and pre-dementia stages. The study will rely on the dementia cohort based on Chinese population to explore the biological phenotype characteristics of the pre-dementia stage and different dementia subtypes, and observe the dynamic change rules of the dementia cohort vertically, so as to foster early intervention and improve prognosis for individuals with dementia.
Status | Not yet recruiting |
Enrollment | 3000 |
Est. completion date | May 10, 2035 |
Est. primary completion date | May 10, 2034 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | Inclusion Criteria: - Male or female patients aged =40 and =90years; - Chief complaint or others describe a cognitive decline; - Ability to communicate in Chinese; - The patients and their families were informed and signed the informed consent. Exclusion Criteria: - MMSE<10; - There are other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc.); - There are other systemic diseases that can cause cognitive impairment (such as hepatic insufficiency, renal insufficiency, Thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.); - Suffering from a disease that cannot cooperate with the completion of cognitive examination; - There are contraindications to nuclear magnetic resonance; - There is mental and neurodevelopmental delay; - Refuse to draw blood; - Refuse to sign the informed consent. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cuibai Wei,Clinical Professor | Central hospital Affiliated to Shandong First Medical University, Chongqing Medical University, First Hospital of Shijiazhuang City, Tianjin Huanhu Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of change in global cognition as measured by Clinical Dementia Rating (CDR). | Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales CDR. CDR, a multidimensional scale for dementia severity, which scored 0-3, with higher scores indicating worse functioning. | 10 years | |
Secondary | Rate of change in global cognition as measured by Mini-Mental State Examination (MMSE) | Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales MMSE. MMSE scores range from 0-30, with higher scores representing better cognitive function. | 10 years | |
Secondary | Rate of change in global cognition as measured by Montreal Cognitive Assessment (MoCA) | Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales MoCA. MoCA scores range from 0-30, with higher scores representing better cognitive function. | 10 years | |
Secondary | Rate of change in the severity of cognitive impairment as assessed by Alzheimer's Disease Assessment Scale-Cognitive section (ADAS-cog). | Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales ADAS-cog. ADAS-cog scores range from 0-70, with higher scores indicating better global cognitive function. | 10 years | |
Secondary | Rate of change in memory function as assessed by World Health Organization-University of California, Los Angeles, auditory verbal learning test (WHO-UCLA AVLT). | Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like WHO-UCLA AVLT. WHO-UCLA AVLT scores depend on the number of correct words, which ranges from 0-15, with higher scores representing better memory function. | 10 years | |
Secondary | Rate of change in language function as assessed by Boston Naming Test (BNT). | Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like BNT. BNT scores range from 0-30, with higher scores representing better language function. | 10 years | |
Secondary | Rate of change in psychobehavioral symptoms as assessed by Neuropsychiatric Inventory (NPI). | Assess statistically significant difference in score between dementia-P and dementia-S using the neuropsychological scales like NPI. Patient assessment grading scores range from 0-144 in NPI, and caregivers distress grading scores range from 0-60, with 0 representing the best. | 10 years | |
Secondary | Rate of change in activities of daily living as assessed by Alzheimer's Disease Cooperative Study-Activity of Daily Living (ADCS-ADL). | Assess statistically significant difference between in score dementia-P and dementia-S using the neuropsychological scales like ADCS-ADL. ADCS-ADL scores range from 0-54, with higher scores indicating better completion ability. | 10 years |
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